MINNEAPOLIS, Minn. & SAN JUAN, Puerto Rico--(BUSINESS WIRE)--Class counsel announced today that heart patients nationwide implanted with recalled defibrillator leads filed separate lawsuits in Minneapolis, Minnesota, and San Juan, Puerto Rico, against the manufacturer Medtronic Inc., and related companies. Each plaintiff received a cardiac pacemaker/defibrillator combination that was attached to their hearts with a lead wire system manufactured by Medtronic and sold under the brand name Sprint Fidelis. In the case of three of the patients, the Sprint Fidelis lead fractured or frayed, necessitating additional surgery to remove the device and implant a new lead system. The plaintiffs are residents of California, Massachusetts, North Carolina, New York and Oregon.
“The complaints charge that Medtronic has misrepresented the safety of the Sprint Fidelis leads and a large proportion may fracture,” stated class counsel Elizabeth J. Cabraser of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP. “As a result, patients may receive massive, unnecessary electrical shocks or the device may fail to function during a life-threatening cardiac event.”
“The Medtronic Sprint Fidelis lead, compared to competing products, has a significantly higher failure rate that appears in just the first two years after implantation. We are concerned that Medtronic is minimizing the likelihood that patients may need to have their lead surgically removed,” stated Wendy R. Fleishman, a partner at the New York office of Lieff Cabraser. “It is critical that patients with the recalled Medtronic lead promptly meet with their physician and discuss their options.”
Medtronic has not disclosed the precise mechanism of the Sprint Fidelis lead fracture failures. The complaints charge that it appears the defect is attributable to the small diameter of the coil and conductors in the lead and because of this the lead is subject to stress damage both during and after the implant. Fracture eventually occurs when the conductor is critically overstressed.
“The defect is potentially fatal,” explained class counsel Nick J. Drakulich of The Drakulich Firm of San Diego, California. “In the class action lawsuit filed in Minnesota, plaintiffs seek an order from the Court requiring that Medtronic create a treatment fund to monitor the health of all patients with the recalled lead and reimburse patients for all diagnostic and corrective medical and surgical expenses attributable to their faulty leads.”
“Both the patients who have had to undergo unnecessary and invasive surgeries as a result of Medtronic's actions -- which Medtronic has only now begun to admit but has not accepted responsibility for - and those who now fear that their life-saving devices may not save their lives, should have their opportunity to obtain justice,” added Seth R. Lesser of the Locks Law Firm in New York, New York.
Plaintiffs’ Experiences and Allegations
In January 2006, Kelly Luisi of San Diego, California, a plaintiff in the class action lawsuit filed in Minnesota, was implanted with a defibrillator with a Sprint Fidelis lead. As alleged in the complaint, in March 2007, Ms. Luisi experienced frightening episodes of unnecessary shocks. She went to the hospital and was admitted in the emergency department. The Medtronic Representative was present, and when he used his device to interrogate the device, Ms. Luisi’s defibrillator began delivering unnecessary shocks over and over again. The Medtronic Representative did not have a magnet to deenergize the leads, and could not immediately deactivate the device. Ms. Luisi experienced several additional inappropriate and frightening shocks at the emergency room.
Ms. Luisi’s lead was removed in April 2007 as it has fractured. Ms. Luisi was required to undergo additional and complicated surgery to remove and replace the faulty lead.
In the lawsuit filed in Puerto Rico, plaintiff Russell Nelson of Portland, Oregon, received a defibrillator heart with a Sprint Fidelis lead in March 2005. The lead was found to have “frayed” in the nature of a fracture and was replaced in an emergency surgery in January of 2007.
In October 2005, George Anastas, a resident of Westminister, Massachusetts, and also a plaintiff in the lawsuit filed in Puerto Rico, received a defibrillator with a Sprint Fidelis lead.
The complaint charges that in May 2006, Mr. Anastas experienced frightening episodes of unnecessary shocks. He went to the hospital and was admitted in the emergency department. A Medtronic representative was present, and when he used his device to interrogate the defibrillator, it began delivering repetitive unnecessary shocks. The Medtronic representative did not have a magnet to deenergize the leads, and could not immediately deactivate the device. Mr. Anastas experienced several additional inappropriate and frightening shocks at the emergency room.
As was the case with Ms. Luisi, the Medtronic lead system inside Mr. Anastas had fractured. Mr. Anastas was therefore forced to undergo additional and complicated surgery to remove and replace the faulty lead.
Information for Heart Patients
On October 15, 2007, due to reports of adverse events and at least five patient deaths with defibrillator leads sold under the brand name Sprint Fidelis, Medtronic issued a recall of the product.
Leads are the thin insulated wires connected to a defibrillator that carry electric impulses to the heart. Your wallet card will specify the manufacturer of your defibrillator leads If you would like to learn more about the Medtronic recall and your legal rights, please visit http://www.personalinjurylawyeramerica.com
Patients that have had to undergo surgery to replace a faulty lead or have been advised by a physician their lead may be defective are also welcome to call class counsel toll free at 1-800-541-7358 and ask to speak to attorney Heather A. Foster at Lieff Cabraser Heimann & Bernstein, LLP.
Resources for Reporters
Reporters that wish to receive a copy of the class action complaint are welcome to contact Stephen Cassidy at Lieff Cabraser at firstname.lastname@example.org or (415) 956-1000.
About Plaintiffs’ Counsel
Representing plaintiffs in the Minnesota class action lawsuit are Daniel E. Gustafson, Gustafson Gluek PLLC; Elizabeth J. Cabraser, Wendy R. Fleishman and Rebecca Bedwell-Coll, Lieff, Cabraser, Heimann & Bernstein, LLP; Silvija A. Strikis, Kellogg, Huber, Hansen, Todd, Evans & Figel, PLLC; Nicholas J. Drakulich, The Drakulich Firm; Jennings & Drakulich, LLP; Richard J. Arsenault, Neblett, Beard & Arsenault; Hunter J. Shkolnik, Rheingold, Valet, Rheingold, Shkolnik & Mccartney LLP; and Seth R. Lesser, Locks Law Firm.
Representing plaintiffs in the Puerto Rico lawsuit are John F. Nevares, Smith & Nevares; Camillo K. Salas, III, Salas & Co.; Richard J. Arsenault, Neblett, Beard & Arsenault; Elizabeth J. Cabraser, Wendy R. Fleishman and Rebecca Bedwell-Coll, Lieff, Cabraser, Heimann & Bernstein, LLP; Nicholas A. Drakulich, The Drakulich Firm; Jennings & Drakulich, LLP; Daniel E. Gustafson, Gustafson Gluek PLLC; Seth R. Lesser, Locks Law Firm; Hunter J. Shkolnik, Rheingold, Valet, Rheingold, Shkolnik & Mccartney LLP; and Silvija A. Strikis, Kellogg, Huber, Hansen, Todd, Evans & Figel, PLLC.